Two-Component Mixing and Dispensing Device

ABSTRACT

A device ( 10 ) for preparing and ejecting polymeric cement made from at least two pre-packaged components comprises a tubular vessel ( 12 ) including a first axial end wall ( 14 ) having a closed outlet ( 16 ), and a second axial end wall ( 18 ) having an aperture ( 20 ). A first starting component ( 50 ) of the polymeric cement is present inside said tubular vessel near the first axial end wall ( 14 ) A shaft ( 22 ) extends through said aperture ( 20 ) of the second axial end wall ( 18 ). A piston element ( 34 ) comprises a closed container ( 36 ) filled with a second starting component ( 46 ) of the polymeric cement. The piston element ( 34 ) is selectively lockable to the shaft ( 22 ). The container has a bore ( 38 ) and is slidingly engaged upon said shaft. An agitator element ( 24 ) is secured to one end of the shaft ( 22 ). Furthermore opening means ( 56 ) for providing an opening in the closed container ( 36 ) are provided

The invention relates to a device for preparing and delivering polymericcement made from at least two pre-packaged components, in particularpolymeric cement for use in vertebroplasty. Such polymeric cement isprepared by mixing starting components, most frequently a solid, e.g.powdered polymeric component and a liquid monomer component. Aftermixing the cement is applied to the location to be treated and allowedto cure. This invention allows the preparation and delivery of polymericcement in situ, in particular in an operating room environment.

Polymeric cement compositions are frequently used in orthopaedic surgeryas a bonding material to set implants and artificial joints in bones.The polymeric cement is prepared in the operating room during anoperation as needed in view of its fast curing. Various apparatuses andmethods for preparing and delivering such cement compositions are knownin the art ranging from motorized table-top mixing machines for mixingonly to hand-operated devices that fulfil both functions of mixing anddelivering.

WO 01/83094 discloses a polymeric bone cement mixing and injectiondevice that is operated by hand. This known device comprises a vesselholding polymer powder and a disk agitator mounted on a shaft passingthrough an aperture in an end wall of the vessel and extending beyondthe agitator through a delivery port in the opposite wall of the vessel.A piston can be selectively coupled to the agitator disk. In order toeject prepared cement, it is necessary to break a distal section of theshaft that passes through the delivery port, mounting the broken offsection of the shaft over an external bushing surrounding the deliveryport and moving the piston toward the delivery port. In this knowndevice a volume of polymer powder is packed in a sterilized andevacuated vessel, after which the vessel thus filled is packaged in asterile envelope. The liquid component is drawn into a syringe and theninjected through the sterile envelope and an elastomeric, self-sealingdiaphragm in the wall of the vessel.

This known device has several drawbacks First of all, the pre-packageddevice comprises only one of the starting components for preparing thepolymeric cement. It is still necessary to introduce the other liquidcomponent into the vessel, when polymeric cement is needed. Thisrequires additional actions of the operating staff, as well as carefulattention in dosing the appropriate amount of liquid component.Furthermore, after mixing the shaft has to be broken, and attached tothe piston in order to eject the cement from the vessel. In fact, twoseparate handles are needed, one for actuating the agitator element fromone side of the device and one for actuating the piston from the otherside. Thus operation of this known device is time-consuming andlabour-intensive. Moreover there is always a risk that the shaft doesnot break at the right position, thereby seriously disturbing the actionof this device.

EP-B1-0 882 436 has disclosed a transport and process device fortwo-component material, wherein a liquid starting component and a powderstarting component are contained in respective transport chambersseparated by a membrane in a closable container. During operation, themembrane is destroyed by a relative movement between the transportchamber for the liquid component and a solid body contained in thecontainer in order to effect a flow of liquid component into thetransport chamber of the powder component. Furthermore, the device hasan ejection piston at one end of the container opposite to the transportchamber for the liquid component. A manually operated agitator elementis situated in the transport chamber for powder component, between theejection piston and the transport chamber for the liquid. Again theagitator element and ejection piston are operated from different sidesby separate mechanisms.

Therefore there is a general need to improve the handling of suchdevices.

One object of the invention is to provide a device for preparing andejecting an at least two-component cement, wherein the at least twostarting components are pre-packaged, and wherein preparation andejection are performed by a single shaft.

According to the invention this object is achieved by a device forpreparing and ejecting polymeric cement made from at least twopre-packaged components, said device comprising:

a tubular vessel including a first axial end wall having a closedoutlet, and a second axial end wall having an aperture, wherein a firststarting component of the polymeric cement is present inside saidtubular vessel near the first axial end wall;

a shaft extending through said aperture of the second axial end wall,having a first section outside said vessel and a second section insidesaid vessel;

a piston element comprising a closed container filled with a secondstarting component of the polymeric cement, the container having a boreand being slidingly engaged upon the second section of said shaft;

an agitator element mounted on the end of the second section of saidshaft;

wherein said piston element is selectively lockable to said shaft; and

wherein opening means for providing an opening in said closed containerare provided, which opening means are operable by said shaft.

The device according to the invention comprises a tubular body. A firstend wall is connected to one end of the tubular body. This end wall isprovided with a closed outlet, through which cement is ejected afterpreparation and removal of the closure from the outlet. A second axialend wall is situated opposite to the first end wall. This second endwall may be a lid or the like, removably connected to the tubular bodysuch as a screw cap. This second end wall is provided with an aperturethrough which a shaft extends. At the outer end situated outside thetubular body, the shaft is usually provided with a handle in order toimprove the grip on the shaft. At the other end situated in the tubularbody, the shaft is provided with an agitator element. A piston elementis arranged in the tubular body between the agitator element and thesecond end wall. In addition to its function as ejection piston, thispiston element is designed in such a way that it serves as a closedcontainer for pre-packaging one of the starting components of the cementcomposition to be prepared. This piston element has a bore. The shaftextends through this bore and is displaceable at least to some extent ina first position. In this first position, a relative movement betweenthe piston element and the tubular body is not possible or effectivelyprevented. In this first position, the piston element, part of thetubular body and the first end wall define a chamber containing theother component of the cement composition. The agitator element ismovable between the first end wall and the piston element. The pistonelement is also lockable to the shaft (a second position). In thissecond position the piston element can be displaced axially uponmovement of the shaft, thereby ejecting the prepared cement through theoutlet into the above-mentioned chamber. In order to introduce thecomponent contained in the piston element the device is also providedwith opening means for opening the closed container. These opening meansare also operable by the shaft.

A significant advantage of the device according to the invention is thatsubsequent operation of one and the same shaft allows for disrupting theseparation between the components, mixing thereof and then ejecting thecement prepared in this way. Another advantage of the device accordingto the invention is that the starting components of the cement arecontained in a pre-packaged manner in appropriate amounts, thus avoidingthe need of accurately dosing one or more components when the cement isneeded.

The polymeric cement made from the starting components can be used asconventional bone cement. However, the device according to the inventionis especially useful in vertebroplasty, e.g. interventional radiologytreatment for pain of spinal fractures caused by osteoporosis.

Hereinafter the invention will be illustrated in more detail in view ofthe accompanying drawings, wherein

FIG. 1 shows an embodiment of a device according to the invention incross-section;

FIG. 2 shows a detail of the embodiment of FIG. 1 in a position foropening the container of the piston element; and

FIG. 3 shows a detail of the embodiment of FIG. 1 during ejection.

In a preferred embodiment of the device according to the invention, theshaft is hollow and is provided with a venting port at its outside end.When the cement is prepared from the starting components, noxious gassesmay form and create bubbles in the mixture. Or the starting componentsthemselves may be harmful. Furthermore, air bubbles may likewise beincluded in the preparation as a result of the mixing action. Thepresence thereof in the final cement is disadvantageous, as these gassesgive rise to porosity and reduced strength. In order to prevent theoccurrence of these bubbles in the cement mixture, this embodiment ofthe device according to the invention has a hollow shaft, which is openat the end situated in the tubular body. At the other end the shaft isprovided with a venting port for discharging gas. More preferably thisventing port is connectable to a vacuum source or other suitableapparatus for generating reduced pressure in the tubular body. Theventing port is advantageously provided with a one-way valve.

As already mentioned, the piston element is lockable to the shaft. Thismay be possible by engagement of the piston element directly by theshaft, or indirectly e.g. by an agitator element which is fixedlyconnected to the shaft. In a preferred embodiment the bottom part of thebore of the piston element through which the shaft extends is providedwith an (inner) screw thread section, while the shaft adjacent theagitator element is provided with a cooperating (outer) screw threadsection. In order to mix the components, the shaft and thereby theagitator element is displaced axially. After mixing, the shaft isretracted until the screw thread portions contact each other, andsubsequently the piston element is coupled to the shaft by rotating theshaft. Usually the friction of the piston element against the inner wallof the tubular body will be sufficient to withstand the rotational forceexerted by the shaft. If needed, additional retaining means may beprovided for maintaining the piston element in its position during thisstep.

In a further preferred embodiment the cross-section of the tubular bodyof the device according to the invention is non-circular. In such anembodiment the piston element will also have a non-circularcross-section. In this case this non-circular cross-section will preventradial movement of the piston element with respect to the shaft. Morepreferably, the cross-section has an elliptical shape.

In yet another preferred embodiment, the opening means comprise at leastone puncturing element for puncturing the wall of the container. Such apuncturing element, e.g. a sharp protrusion on that side of the agitatorelement facing the piston element, allows making one or more holes inthe wall of the container wherein one of the starting components isstored, by suitable handling the shaft. This component flows out of thecontainer into the chamber holding the other component. Then thecomponents are mixed thoroughly by moving the shaft and attachedagitator element to and fro. Some rotational movement may be performedfor increasing the mixing action. More preferably the puncturing elementis a hollow needle. Advantageously, the container may be provided withlocations having a reduced strength, e.g. a reduced wall thickness, uponwhich the puncturing elements act. This will increase the reliability ofdisrupting the separation between the components.

As indicated above, preferably the puncturing element is connected tothe agitator element. If there is a risk that the puncturing elementswill hold the container wall firmly so that the puncturing elements andpiston element will move together from that moment on, in an alternativeembodiment the puncturing elements are arranged on a separate plate e.g.disk, slidingly engaged by the shaft, the top of the puncturing elementsbeing directed to the piston element. In this embodiment the openingfunction to open the container and the mixing function are provided byseparate items that are not fixedly connected to one another.

Preferably, the component contained in the piston element is a liquidcomponent, while the component contained in the tubular body itself is aparticulate component. Upon rupturing the container wall in an almostvertical position having the outlet opening downwards, the liquidcomponent will flow out the container easily due to gravity or appliedvacuum. An example of a polymeric bone cement that can be suitablyprepared in a device according to the invention, is acryl based cement.

The attached drawings show an embodiment of a device according to theinvention during several stages.

FIG. 1 shows a device for preparing and ejecting polymeric cement madefrom two components, e.g. a particulate polymer and a liquid monomer.The device indicated in general by reference numeral. 10, holds thestarting components in separated spaces in appropriate amounts. Thedevice 10 comprises a tubular body 12 having an elliptical cross-section(see FIG. 2) and a first axial end wall 14. The first end wall 14 isprovided with an outlet 16, onto which a closure or a suitable nozzle(not shown) can be fitted by means of a screw thread connection. Asecond axial end wall, in this embodiment a screw cap 18 having aninternal screw thread portion is mounted on the other end of the tubularbody 10 opposite to the first axial end wall 14. The screw cap 18 has acentral aperture 20. A shaft 22 extends through the aperture 20 from theoutside into the tubular body 12. An agitator element 24 is mounted atthe inner end 26 of this shaft 22. The agitator element 24 comprises adisk 28 having recesses 30 in its periphery, as well as holes 32, whichallow passing the mixture from one side to the other. A piston element34 is arranged between the agitator element 24 and the screw cap 18. Thepiston element 34 comprises an annular container 36 having a centralbore 38. The bore 38 has an inner screw thread section 40 (see FIGS. 2and 3) at its bottom, and a generally smooth upper section 42, whichslidingly engages the shaft 22 in the position shown in FIG. 1. Theshaft 22 comprises a co-operating threaded section 43 adjacent theagitator element 24. A sealing gasket 44 is provided on top of thepiston element 34. The dimensions of the piston element 34 have beendesigned such that the piston element 34 fits into the tubular body 12and retains its position thereby. The t container 36 contains a liquidmonomer (indicated by short lines 46) as one of the starting componentsfor the polymerization reaction in order to prepare cement. A part ofthe tubular body 12 together with the first axial end wall 14 and thepiston element 34 define a chamber generally indicated by referencenumeral 48, wherein powder particles 50 of a polymer as the otherstarting component are contained. The side 52 of the agitator element 24facing towards the piston element 34 supports opening means 54, whichare in this case hollow needles 56 having an opening 58 in theperipheral wall 60 and an open bottom end 62. The agitator element 24 ismounted between two annular plates 64 fixed to the shaft 22. See FIG. 2.The annular plates 64 have a smaller radius than the agitator element 24itself so that the recesses 30 and holes 32 remain open. The shaft 22comprises an axial channel 66 extending between an open bottom end 26and a top end 70 which is provided with a vacuum port 72 having aone-way valve 74. This vacuum port 72 is arranged in handle 76. A snapconnection 78 for fast connection to a vacuum source is mounted onto thevacuum port 72. Generally the device 10 having the pre-packagedcomponents 46 and 50 will be packaged itself in a suitable pliable andsterile envelope.

When polymeric cement is needed, this envelope is removed. If the shaftwas locked during transport and storage, this lock is released. Byoperating the handle 76, the shaft 22 is drawn outwardly. Thereby theagitator element 24 is displaced in the same direction, as a result ofwhich the hollow needles 56 puncture weakened spots 80 in the bottom ofthe container 36 allowing the liquid monomer contained in the container36 to flow into the chamber 48. See FIG. 2. The shaft 22 is thendisplaced to and fro for a number of times, thereby intimately mixingthe liquid monomer 46 and polymer particles 50. When the mixture thusprepared is needed, the shaft 22 is again retracted until the screwthread portion 43 of the shaft 22 contacts the corresponding screwthread portion 40 of the bore 38. Then the operator performs arotational movement of the shaft 22, thereby screwing the piston element34 onto the shaft 22. See FIG. 3. As the tubular body 12 has anelliptical cross-section in this embodiment, rotational movement of thepiston element 34 together with the shaft 22 is not possible. Once theshaft 22 is fastened to the piston element 34, the cement mixture can bepressed through the outlet 16 in the first end wall 14 after replacementof the outlet cap by a suitable nozzle.

1. A device for preparing and ejecting polymeric cement made from atleast two pre-packaged components, said device comprising: a tubularvessel including a first axial end wall having a closed outlet, and asecond axial end wall having an aperture, wherein a first startingcomponent of the polymeric cement is present inside said tubular vesselnear the first axial end wall; a shaft extending through said apertureof the second axial end wall, having a first section outside said vesseland a second section inside said vessel; a piston element comprising aclosed container filled with a second starting component of thepolymeric cement, the container having a bore and being slidinglyengaged upon the second section of said shaft; an agitator elementmounted on the end of the second section of said shaft; wherein saidpiston element is selectively lockable to said shaft; and whereinopening means for providing an opening in said closed container areprovided, which opening means are operable by said shaft.
 2. A deviceaccording to claim 1, wherein said shaft is hollow, and is provided witha venting port.
 3. A device according to claim 1, wherein the shaft isprovided with a screw thread section near the agitator element, and thebore of the container is also provided partly with a co-operating screwthread section.
 4. A device according to claim 1, wherein the tubularvessel has a non-circular cross-section.
 5. A device according to claim4, wherein the tubular vessel has an elliptical cross-section.
 6. Adevice according to claim 1, wherein the opening means comprise at leastone puncturing element for puncturing the wall of the container.
 7. Adevice according to claim 6, wherein said puncturing element is a hollowneedle.
 8. A device according to claim 1, wherein said opening means arefixed to the agitator element.
 9. A device according to claim 1, whereinthe opening means are provided on a plate slidingly engaged upon thesecond section of the shaft and arranged between the agitator elementand the piston element.
 10. A device according to claim 1, wherein thefirst component is solid particulate material, and the second componentis liquid.
 11. A device for preparing and ejecting polymeric cement madefrom at least two pre-packaged components, said device comprising: atubular vessel including a first axial end wall having a closed outlet,and a second axial end wall having an aperture, wherein a first startingcomponent of the polymeric cement is present inside said tubular vesselnear the first axial end wall; a hollow shaft extending through saidaperture of the second axial end wall, having a first section outsidesaid vessel and a second section inside said vessel; a piston elementcomprising a closed container filled with a second starting component ofthe polymeric cement, the container having a bore and being slidinglyengaged upon the second section of said shaft; an agitator elementmounted on the end of the second section of said shaft; wherein saidpiston element is selectively lockable to said shaft; wherein openingmeans for providing an opening in said closed container are provided,which opening means are operable by said shaft; and wherein the openingmeans comprise at least one puncturing element for puncturing the wallof the container.
 12. A device according to claim 11, wherein thetubular vessel has a non-circular cross-section.
 13. A device accordingto claim 11, wherein the tubular vessel has an elliptical cross-section.14. A device according to claim 11, wherein the opening means compriseat least one puncturing element for puncturing the wall of thecontainer.
 15. A device for preparing and ejecting polymeric cement madefrom at least two pre-packaged components, a first component of solidparticulate material, and a second component of liquid, said devicecomprising: a tubular vessel including a first axial end wall having aclosed outlet, and a second axial end wall having an aperture, wherein afirst starting component of the polymeric cement is present inside saidtubular vessel near the first axial end wall; a hollow shaft extendingthrough said aperture of the second axial end wall, having a firstsection outside said vessel and a second section inside said vessel,said shaft provided with a venting port; a piston element comprising aclosed container filled with a second starting component of thepolymeric cement, the container having a bore and being slidinglyengaged upon the second section of said shaft; an agitator elementmounted on the end of the second section of said shaft; wherein saidpiston element is selectively lockable to said shaft; wherein openingmeans for providing an opening in said closed container are provided,which opening means are operable by said shaft; and wherein the openingmeans comprise at least one puncturing element for puncturing the wallof the container.
 16. A device according to claim 15, wherein the shaftis provided with a screw thread section near the agitator element, andthe bore of the container is also provided partly with a co-operatingscrew thread section.
 17. A device according to claim 15, wherein saidpuncturing element is a hollow needle.
 18. A device according to claim15, wherein the opening means are provided on a plate slidingly engagedupon the second section of the shaft and arranged between the agitatorelement and the piston element.